Medical Devices OEM Supplier | BP Monitors, Thermometers

Medical Devices

Medical Devices OEM Manufacturer & Private Label Supplier

The diagnostic and monitoring range for private-label programmes: blood pressure monitors, glucose meters and strips, thermometers, pulse oximeters, mesh nebulizers, oxygen concentrators, TENS/EMS units and pregnancy tests. Production runs in ISO 13485:2016-certified partner plants, CE marking applies to the models that carry it, and each SKU ships with the technical file, test reports and labelling artwork your importer will be asked for.

  • MOQ from 500 pcs
  • Sample dispatched in 3–5 working days
  • CE / FDA documentation support
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Medical Devices

Upper-Arm Digital Blood Pressure Monitor

Upper-Arm Digital Blood Pressure Monitor

Oscillometric measurement, large LCD backlit display, dual-user 99 memory sets, IHB detection, adjustable cuff 22-42cm.

Why it sellsOne cuff covers 22–42 cm, so a pharmacy stocks a single SKU instead of guessing the ratio between standard and large sizes.
What to watchCuff fit and power supply are what generate after-sales calls — an undersized cuff reads high. The wide-range cuff and AA-or-USB power exist to cut that volume.
  • MOQ 500
  • Sample 3 days
  • 25–30 days
  • Documents on request
Full spec sheet →
Blood Glucose Monitoring System

Blood Glucose Monitoring System

5-second results, 0.6μL sample, 500 memory records, 7/14/30/60/90 day averages. Kit includes meter, 50 strips, lancing pen and 100 lancets.

Why it sellsFive seconds and a 20–600 mg/dL range is what makes the meter usable in a clinic queue, not only at a kitchen table.
What to watchStrips decide repeat revenue and repeat complaints, not the meter: a tired strip lot looks like a broken device, and the buyer blames the unit you sold.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
Non-Contact Infrared Thermometer

Non-Contact Infrared Thermometer

1-second reading, body/surface dual mode, tri-color fever alert, 32-set memory, CE marked · FDA Establishment Registration.

Why it sellsClinics, pharmacies and schools replace a drawer of glass thermometers with one unit — and it reorders alongside the hygiene consumables.
What to watchDrift, not breakage: a dropped unit reads low for months before anyone notices. Every unit is checked against a blackbody reference before packing, and the calibration record ships with the batch.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
Fingertip Pulse Oximeter

Fingertip Pulse Oximeter

SpO2 and pulse rate in 8 seconds, dual-color OLED 4-way rotation, auto power-off, 30-hour runtime.

Why it sellsLow unit price, obvious function, nothing to explain at the counter — it sells on a shelf and online, in every market, all year.
What to watchThe display and the spring in the hinge fail first, and that is what comes back as returns. We test both before the carton is sealed.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
Portable Mesh Nebulizer

Portable Mesh Nebulizer

Piezoelectric micro-mesh, ≤3.7 µm particles, 0.5–18 mL cup, 20-minute auto shut-off, 2× AA or USB power, includes adult/child masks and nozzle.

Why it sellsA 0.5–18 mL cup and two-way power cover both a paediatric dose and a full session, and ≤3.7 µm keeps it comparable to a compressor for the drugs the IFU lists.
What to watchTwo AA cells ship separately — decide whether the retail pack includes them. The mesh still clogs before anything else fails, so rinsing after each use is the whole maintenance schedule.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • ISO 13485 facility
Full spec sheet →
Digital Thermometer

Digital Thermometer

Waterproof flexible soft tip, fast 10-30s reading, oral/axillary/rectal use, auto power-off, ±0.1°C accuracy.

Why it sellsA ±0.1 °C figure taken from the technical file is one a pharmacy can print next to the price without being challenged.
What to watchButton cells die mid-illness, exactly when the reading matters. Auto power-off stretches the LR41, but the spare cell is the accessory buyers forget to stock.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
Portable Oxygen Concentrator

Portable Oxygen Concentrator

PSA technology, 1-3 L/min adjustable, 93%±3% concentration, <45dB, programmable timer, remote control.

Why it sells1–3 L/min at ≤45 dB covers the prescription range a home-care customer specifies and is quiet enough to run in a bedroom overnight.
What to watchFilters and battery are the wear items; a clogged intake drops concentration before any alarm sounds. Sieve beds age with running hours, not with the calendar.
  • MOQ 500
  • Sample on request
  • 25–30 days
  • CE
Full spec sheet →
Smart Digital Body Scale

Smart Digital Body Scale

180kg capacity, 4 high-precision sensors, hidden LED, tempered glass, BMI calculation, optional Bluetooth.

Why it sells180 kg covers general retail and bariatric users in one SKU, and 100 g steps let a user see week-to-week movement.
What to watchThe glass platform and the feet are the failure points, not the sensors; a scale that reads differently on carpet is returned as inaccurate.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • Documents on request
Full spec sheet →
Pregnancy Test Kit

Pregnancy Test Kit

>99% accuracy, detects hCG up to 5 days before expected period, clear line result in 5 min, 5 sticks + cups.

Why it sellsA visible control line is what makes a strip result defensible for a pharmacy brand — the customer can see the test ran.
What to watchReading time is the error source: too early, too late, or a strip left on the sink. The window in the IFU is what the complaint usually turns on.
  • MOQ 5,000
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
TENS/EMS Therapy Device

TENS/EMS Therapy Device

16 programs, 20 intensity levels, dual independent channels, TENS pain relief + EMS muscle stimulation, 4 pads.

Why it sellsIndependent dual channels with 16 programmes is what separates a clinic unit from a consumer toy at the same shelf price.
What to watchPads are the consumable and the complaint: adhesive dies after a few sessions, and a device blamed for weak output usually has tired pads.
  • MOQ 500
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →
Digital Pregnancy Test

Digital Pregnancy Test

Reusable digital monitor with disposable hCG sticks, HCG1+/2+/3+ readout with gestational age, >99% accuracy at 25 mIU/mL, ~5-minute result.

Why it sellsA reusable monitor with disposable sticks is the retail model that brings the buyer back for refills instead of a new box each time.
What to watchThe monitor is reusable, so the failure sits in the sticks: foil opened too long reads invalid, and the device gets the blame.
  • MOQ 1,000
  • Sample 3–5 days
  • 25–30 days
  • CE · FDA facility
Full spec sheet →

Frequently asked questions

Do these devices need CE marking or FDA clearance?

They are two separate routes. CE marking is an EU conformity route supported by a technical file and, depending on device class, a notified-body assessment. The FDA route starts with establishment registration and requires 510(k) clearance for most Class II devices. We supply the technical file and test reports; the declaration of conformity is issued in the brand owner's name, not ours.

Which of these products are IVD rather than medical devices?

The pregnancy tests and the glucose test strips are in vitro diagnostic products, regulated under the EU IVDR and under 21 CFR 809 in the US — not the MDR. That means a different technical file, different performance studies and, for self-test IVDs, a notified-body review in the EU. If your market is the EU, plan the IVDR route for those SKUs early.

Which standards do the monitors get tested against?

Typically IEC 60601-1 for electrical safety and IEC 60601-1-2 for EMC, plus device standards: ISO 81060-2 for non-invasive blood pressure, ISO 80601-2-61 for pulse oximeters, ISO 80601-2-56 and ASTM E1112 for clinical thermometers, ISO 27427 for nebulizers. Reports are provided per confirmed model — tell us which SKU and market before ordering.

What is the MOQ and sampling timeline?

Standard models start from 500 units; 100-unit trial orders are possible for repeat buyers. Existing samples ship in 3–5 working days, customised housing, packaging or manual take 15–25 days.

How are battery-powered devices shipped?

Units with lithium cells ship with UN38.3 test summaries and an MSDS, packed to IATA or IMDG requirements depending on mode. The oxygen concentrator moves as a non-DG shipment by sea or air with the compressor documented separately. Give us the destination port and we quote the correct mode.

Ready to price a medical device programme?

Send the model, target quantity and destination market — we reply within one business day (08:30–18:00 GMT+8) with FOB pricing, lead time and the document list for your market.

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